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Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy | Clinical Trials | Clareo Health

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Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

NCT00358124•Sanofi

View on ClinicalTrials.gov

Summary

To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of type 2 diabetes mellitus for at least one year;
•Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
•Glycated hemoglobin between 7.5 and 11 % units, inclusive;
•Willingness to accept, and ability to inject insulin glargine therapy

Exclusion Criteria

•Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
•Congestive heart failure requiring pharmacological treatment;
•Serum creatinine \> 1.5 mg/dl for males, or \> 1.4 mg/dl for females;
•Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
•Planned radiological examinations requiring administration of contrasting agents;
•Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
•History of hypoglycemia unawareness;
•Pregnancy or lactation;
•Failure to use adequate contraception (women of current reproductive potential only);
•Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
+5 more criteria

Locations (1)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Key Dates

Start Date

January 1, 2001

Completion Date

June 1, 2002

Last Updated

January 11, 2011

Enrollment

220

Estimated participants

Conditions

Type 2 Diabetes Mellitus

Interventions

insulin glargine

DRUG

rosiglitazone

DRUG

metformin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

Inclusion Criteria

Exclusion Criteria

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